FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services

Registration of Food Facilities

October 2003
Overview & Background

The Law:
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.

Who must register?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.

Domestic facilities are required to register whether or not food from the facility enters interstate commerce.

Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

Examples of FDA-regulated Foods

  • Food and food additives for man or animals
  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverages (including alcoholic beverages and bottled water)
  • Fruits and vegetables
  • Fish and seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Canned foods
  • Live food animals
  • Bakery goods, snack food, and candy

Is there a registration fee?
No registration fee is required. More...

What facilities are exempted from registration?
Exempt from registration are farms; retail food establishments; restaurants; non-profit establishments that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing [as defined in 21 CFR 123.3 (k)]; and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture. More...

How long will this take?
FDA estimates that it will take one or two hours of a manager's time to read and understand the regulations. Filling out a registration form would take a total of one hour -- 45 minutes of an administrative worker's time and 15 minutes of an owner, operator, or agent-in-charge's time to certify the registration before submitting the form to FDA. More...

Electronic Registration via the Internet

FDA Notice Regarding Firms Offering
Registration Services

How to Register (or Update) a Food Facility Online

  1. Verify that your computer system meets the minimum system requirements.
  2. Create an Account for the online FDA Industry Systems.
  3. Register or Update a Food Facility.

Login now

1. Computer System Requirements:

Is your computer secure? Before using FDA Industry Systems (FIS), FDA strongly encourages all users to have current antivirus and antispyware software installed on their computers to help ensure the privacy of the information being entered.

  1. Internet Access
    Internet access is widely available, including at public libraries and Internet cafes.
  2. Web Browser
    The online registration system supports the following web browsers:
    • Microsoft Internet Explorer
      Versions 5.5, 6.0
    • Netscape Navigator
      Version 7.1
    • Opera
      Version 7.0
  3. Additional hints

2. Create an Account

In order to log in , you must first have an account. If you do not have an account, you must create one or have one created for you(*). Once you have an account, you can log in to the online FDA Industry Systems to register your food facility.

When you create your own account, it may be used in order to register a single food facility or multiple facilities. When you create your own Account, you will create your own password and are immediately logged into the online systems after creating the account. More...

To create an Account, go to the Login screen and choose Create an Account. Choose the Food Facility Registration Module as the system you want access to, then fill out the series of screens that follow.
(See Quick Start or Step-by-Step)

*Some companies may also wish to create subaccounts so additional personnel can help manage registration of one or more facilities. This is not required.

3. Register (or Update) a Food Facility

FDA Notice Regarding Firms Offering
Registration Services

After you create your account, or when you come back later and log in, choose the Food Facility Registration menu option.
(See Quick Start or Step-by-Step, or
Update Facility Registration Step-by-Step)

Things you should know:

Before you start, we recommend that you collect all the information you will need. (See Fact Sheet and summary of fields in Form 3537.) If you need to look something up after you start, be aware that the system will automatically log you off after 30 minutes of inactivity. If you stop with a partially completed registration, none of the information will be saved, and you will need to start from the beginning when you log in again.

OMB Approval Number: 0910-0502
OMB Expiration Date: 05/31/2010
See OMB Burden Statement.

System Status Help Desk
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